UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama". :A randomization open-label, non-eating simultaneous control comparison group study.
Title of the study (Brief title)	The clinical trial for anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
Region	Japan

Condition
Condition	Healthy adults.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical benefits, such as anti-fatigue effect, associated with four weeks daily ingestion of ripe kumquats "Tama-Tama" for the healthy adult.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Total score of Chalder fatigue scale at first day, four weeks and eight weeks after ingestion of ripe kumquats.
Key secondary outcomes	1. VAS score 2. QOL scales (SF-36) 3. Symptom scores of upper respiratory tract infections(URTI) 4. Duration of illness, the number of days from the onset to the complete disappearance of URTI symptoms 5. Percentage of visiting physicians due to symptoms of URTI 6. Incidence rate of influenza 7. Restriction of daily activities 8. Adverse events (VAS score and QOL scales are assessed on the first day, four weeks and eight weeks after ingestion of ripe kumquats "Tama-Tama".)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects take Kumquat "Tama-Tama" five pieces per day for four weeks
Interventions/Control_2	The subjects don't take Kumquat "Tama-Tama" for four weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	35 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who are 35-55 years old at informed consent. 3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1. Subjects who don't fill any item of self-reported health questionnaire. 2. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire. 3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who are heavy smoker (more than 21 cigarettes per day), alcohol dependency or drug dependency or who have possibility of these dependency. 8. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 9. Pregnant or lactating women or women expect to be pregnant during this study. 10. Subjects who have cognitive disorder or who have possibility of the disorder. 11. Subjects who participate and take the study drug in other clinical trials before this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size	56

Research contact person
Name of lead principal investigator	Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Homepage URL
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	Miyazaki Brand Promotion Headquarters
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 02 Month 15 Day
Last follow-up date	2017 Year 04 Month 23 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 06 Month 13 Day
Date analysis concluded	2017 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2018 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030081